510(k) · Cleared
ClearedNuFACE Trinity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carol Cole Company Dba Nuface · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Oct 11, 2018 as substantially equivalent to K103472 (Carol Cole Company, 2011) after a 177-day review. Its family tree reaches back 3 generations to 2001. 22 later devices descend from it.
- Decided
- Oct 11, 2018
- Review
- 177 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011935 (2001). 4 ancestors in all. 22 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 2 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 1 generation backK103472 Nuface PlusCarol Cole Company · 2011
- This deviceK181008 NuFACE TrinityCarol Cole Company Dba Nuface · 2018
- Descendant · cites it directly · 13 of its ownK191951 Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021
- Descendant · 2 generations on · 10 of its ownK233010 Beagank 4T PlusBelega, Inc. · 2023
- Descendant · cites it directly · 5 of its ownK201782 NuFace Trinity Plus DeviceCarol Cole Company Dba Nuface · 2021
- Descendant · 3 generations on · 3 of its ownK243430 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 2 of its ownK212342 ZIIP+ DeviceZiip, Inc. · 2021
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K191951Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ DeviceAvazzia, Inc. · 2021 · cites it directly13descendants
- K233010Beagank 4T PlusBelega, Inc. · 2023 · 2 generations on10descendants
- K201782NuFace Trinity Plus DeviceCarol Cole Company Dba Nuface · 2021 · cites it directly5descendants
- K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · 3 generations on3descendants
- K212342ZIIP+ DeviceZiip, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −2 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −1 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| 0 (this device) | K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018 | — |
| +1 | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | Avazzia, Inc. | 2021 | — |
| +2 | K233010 | Beagank 4T Plus | Belega, Inc. | 2023 | — |
| +1 | K201782 | NuFace Trinity Plus Device | Carol Cole Company Dba Nuface | 2021 | — |
| +3 | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +2 | K212342 | ZIIP+ Device | Ziip, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103472 | Nuface PlusSummary page 4…NFO PREDICATE DEVICE The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-the-counter use: 510(k) Number: K103472 Manufacturer: Carol Cole Company dba NuFACE Trade Name: NuFACE Plus Product Code: NFO DEVICE DESCRIPTION… | 2011 |
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K191951 (Avazzia, Inc., 2021) has gone furthest, with 13 descendants of its own.
- 9 other devices also cite its predicate K103472.
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181008 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181008: NuFACE Trinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181008
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026